MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 30IN(75CM) 1 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8425H
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify the lot number involved as the lot number provided in the event description is incomplete (missing a number at the end of the lot number).Please clarify if two devices for product code 8425h, lot ¿am591¿ were involved in this procedure.Please clarify what is the specific quality issue with the suture? the suture separates from the needle or suture broke were fragments of the device left inside the patient? was there any patient consequence? status of product return related medwatch report 2210968-2020-09095.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture came off of the needle and the thread broke easily.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 12/18/2020.Additional information: h6 additional information was requested and the following was obtained: *please clarify what is the specific quality issue with the suture? the suture separates from the needle or suture broke? - the suture, or strand, was released from the assembly and separated from the needle.* were fragments of the device left inside the patient? - no * was there any patient consequence? - no * status of product return - it was disposed of in the medical device material trash, because it was contaminated.Related medwatch reports 2210968-2020-09095.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROLENE SUT 30IN(75CM) 1 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10855520
• Report Number: 2210968-2020-09094
• Device Sequence Number: 16334994
• Product Code: GAW
• UDI-Device Identifier: 10705031015470
• UDI-Public: 10705031015470
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 8425H
• Device Catalogue Number: 8425H
• Device Lot Number: AM5915
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1